Study to Understand Fall Reduction and Vitamin D in You

Principal research objective

To conduct a clinical trial to determine which of four doses of vitamin D pills is the best dose for the prevention of falls in ~1,200 older adults, who are at risk of falling and who have a low serum vitamin D level (10-25 ng/mL)

Sponsor

National Institute on Aging (NIA) of the National Institutes of Health (NIH)

Study population

Adults, ages 70 and older, who are at high risk for falling

Main inclusion criteria

At least one of the following:

Two or more falls in the past year

One fall with injury in the past year

Fear of falling because of balance or walking problems

Difficulty maintaining balance when bathing, dressing, or getting in and out of a chair

Use of a cane, walker, or other device

Serum vitamin D level of 10-25 ng/mL (we will measure this)

Average daily vitamin D supplementation <1,000 IU

Average daily calcium supplementation <1,200 mg

Vitamin D doses to be tested

200 IU per day

1,000 IU per day

2,000 IU per day

4,000 IU per day

Outcomes

Falls

Physical function (gait speed, balance, muscle strength)

Participant experience

Eligibility assessments (over the phone and in-person)

In-person visits at 3, 12, and 24 months after joining at ProHealth in Baltimore (Woodlawn) or the Comstock Center in Hagerstown (both are Johns Hopkins research clinics). Visits will include questionnaires, physical performance tests, and a blood draw.